Cleared Traditional

Stryker Omega PEEK Knotless Anchor System

K202355 · Stryker · Orthopedic
Nov 2020
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K202355 is an FDA 510(k) clearance for the Stryker Omega PEEK Knotless Anchor System, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on November 13, 2020, 86 days after receiving the submission on August 19, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K202355 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2020
Decision Date November 13, 2020
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040